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- FDA places second clinical hold on Regenxbio’s Hunter syndrome gene therapy after spinal masses detectedThe FDA issued another clinical hold on Regenxbio’s RGX-121 gene therapy for Hunter syndrome after investigators found spinal masses in five trial participants. The masses, observed on MRI scans,…
- FDA extends review of Capricor cell therapy; Pain drug startup to go publicThe agency is now reviewing an updated application for deramiocel with a “refined” indication. Elsewhere, a startup co-founded by Vivek Ramaswamy is taking a speedy path to the public markets.BioPharma Dive · 2h ago↗ source